More and more inspections around the world seem to be uncovering data
integrity issues. Do you perform data integrity audits? Do you have a
data governance policy? Do you think the topic is limited to the QC
laboratory and / or computerized systems audit trails and passwords?
This workshop will allow you to benchmark your company against others
and set up or improve a holistic, proactive Data Governance System which
is a part of the Quality System rather than just an add-on.

קהל היעד

Anyone working in the pharmaceutical industry including Company General
Managers, Managing Directors (GMPs and ICH Q10 focusing on management
leadership), QPs, Quality Assurance, Quality Control and other quality
professionals, Operations Managers, production managers, Research and
Development, persons working in technology transfer, personnel working
in pharmaceutical Active substance and finished product manufacture as
well as distributors, brokers, wholesale dealers and anyone involved in
the manufacture of starting materials, Active Substances, finished
pharmaceuticals or involved in the handling, processing or sale or
administration of any of these. Persons involved in clinical trials and
manufacture and administration of Investigational Medicinal Products
will also find the course very useful as will regulatory personnel.

התועלת שתופק

Participants will come away from this course understanding what data
integrity issues are, how they arise and how a comprehensive Data
Governance Policy can reduce the likelihood of systematic data integrity
problems in a company.
Participants will understand how to plan for the future and integrate automated solutions to reduce dependence on “human error.”